BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 9961290 · Received April 15, 2020

    Report

    Report Number
    3005862821-2020-00019
    Event Type
    Injury
    Date Received
    April 15, 2020
    Date of Event
    March 9, 2020
    Report Date
    March 17, 2020
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO NON-CONFORMITY WAS FOUND AFTER OKB REVIEWED ALL MANUFACTURING AND QC RECORDS OF THE SUSPECTED METER (SERIAL#: (B)(4)) AND STRIPS (LOT#: D190509-1). THE METER WAS SHIPPED TO PDC ON 11/15/2019. STRIPS WERE MANUFACTURED ON 05/09/2019 AND WILL EXPIRE IN 05/2021. BECAUSE THE SUSPECTED BGMS WAS NOT RETURNED TO OKB, THE RETAINED METER (SERIAL#: (B)(4)) WAS USED TO RE-TEST, AND THE COMPLAINT SITUATIONS DID NOT OCCUR. BESIDES, DESICCANTS OF RETAINED STRIPS (LOT#: D190509-1) FROM OKB'S WAREHOUSE WERE STILL FUNCTIONAL (ORANGE COLOR). RETAINED STRIPS WERE USED TO RE-TEST WITH IN-HOUSE METER (SERIAL#: (B)(4)) AND CONTROL SOLUTION (LEVEL LOW: BATCH# 8AH1A94, EXP. BY DEC., 2020; LEVEL HIGH: BATCH# 8AH3A14, EXP. BY SEPT., 2020), AND RESULTS (LEVEL LOW: 52/55; LEVEL HIGH: 250/251) MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 35~85; LEVEL HIGH: 220~330). THE ROOT CAUSE OF THE COMPLAINT WAS UNABLE TO BE VERIFIED WITHOUT THE SUSPECTED BGMS AND MORE USERS' INFORMATION. THEREFORE, THE COMPLAINT HAD TO BE CLOSED OUT IF NO FURTHER ACTION OR INFORMATION FROM THE USER.

    Description of Event or Problem · 1

    END-USER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2020 AROUND 2:00PM AT HOME. END-USER STATED THAT SHE TOOK A BLOOD GLUCOSE TEST WITH HER PRODIGY METER AND GOT A RESULT IN THE 300MG/DL. SHE DID NOT TEST AGAIN WITH HER PRODIGY METER. END-USER STATED SHE IS NOT SURE WHAT A NORMAL RESULT WOULD BE FOR HER AT THAT TIME OF DAY. SHE STATED THAT SHE IS UNSURE WHAT HER NORMAL RANGE SHOULD BE. END-USER STATED THAT SHE WAS SWEATING WITH SLURRED SPEECH AND SHE WAS DIZZY. SHE DID NOT CALL PARAMEDICS AND HAD SOMEONE DRIVE HER TO (B)(6) MEDICAL CENTER LOCATED AT (B)(6). THE END-USER STATED THAT WHEN SHE ARRIVED AT THE HOSPITAL HER BLOOD GLUCOSE WAS AROUND 365MG/DL. SHE IS UNSURE OF WHAT TREATMENT SHE RECEIVED DUE TO LOSING CONSCIOUSNESS. SHE STATED THAT SHE HAD AN IV. HER VITAL WERE CHECKED TO ENSURE HER BLOOD PRESSURE WASN'T HIGH. SHE WAS DISCHARGED WITH A BLOOD GLUCOSE OF 160MG/DL. SHE WAS TOLD TO MONITOR HER BLOOD SUGAR AND WATCH WHAT SHE EATS AND LIMIT HER SALT INTAKE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426928 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D190509-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization